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DiGA neotivCare - digital assessment of cognitive status to identify and monitor cognitive impairments

DiGA neotivCare - digital assessment of cognitive status to identify and monitor cognitive impairments

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
DRKS
Registry ID
DRKS00026151
Enrollment
180
Registered
2021-09-14
Start date
2021-10-01
Completion date
Unknown
Last updated
2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

F06.7

Interventions

Group 1: standard of care (SOC) Group 2: Provision and utilisation of the neotivCare APP: the app is a registered and licensed medical product class I (according to the MDD) respectively IIa (accordin

Sponsors

neotiv GmbH
Lead Sponsor

Eligibility

Sex/Gender
All
Age
60 Years to 80 Years

Inclusion criteria

Inclusion criteria: - patients age 60-80 - s4elf report or suspected cognitive impairments - ICD-codes F00*, F01*F02*, F06 - mini mental state exam >25 - smartphone available and competency

Exclusion criteria

Exclusion criteria: - unsable to use a smartphone - no remote mobiel access - severe visual or sensual impairments - other neurological diseases that hinder the use of a phone - anosognosia

Design outcomes

Primary

MeasureTime frame
test anxiety will be measured using the Test nxiety inventory (TAI-G) in its german version by Hosdap (1991) revised by Schwarzer& Jerusalem (1999). general anxiety will be measured using the Generalized Anxiety Disorder (GAD-7) and the physical health questionnaire (PHQ-D). Patient sovereignity will be measured using a newly developed questionnaire that was validated in a pilot study.

Secondary

MeasureTime frame
Secondary outcomes regarding procedures in diagnosis will be assessed using a generic questionnaire and data from physician´s patient records.

Countries

Germany

Contacts

Public ContactPaula Säring

nepotiv GmbH

paula.saering@neotiv.com0391 58 24 5026

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026